How to interpret and Use Laboratory Data to protect the Safety of Subjects in Clinical Research Studies

Duration: 75 Minutes
All Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.
clinical research
Product ID: 500161
The section on "Safety monitoring" includes the array of lab tests taken at prescribed intervals adjudged to answer the safety questions. Whereas evaluation of this safety data is the Investigators responsibility, it is essential for the whole team and the sponsor to be on board with the timing and extent of this testing.

The source of lab data is also important; as for the data to be interpretable it must be accurate, reliable and repeatable. For this reason the choice of a lab following the principles of, or certified in, "GLP" (21 CFR 58) is the goal. Trusting the reference ranges and the data to be reviewed should give assurance as to the verity of what is observed.

The question of the relationship of lab data to "Adverse Event" determination is the decision of the Investigator guided by what is in the protocol. Therefore, careful consideration of what to include as safety data and guidelines for interpretation are important elements of a good protocol. It is also important to see what the FDA regulations and the ICH GCP recommendations are in regard to Adverse Events.

Why Should you Attend:
With the increasing frequency of real-time FDA audits and complexity of Investigational Medicinal Products (IMP’s), the wise are paying more attention to including a full range of lab tests to insure IMP safety. Which lab values outside of the Reference range are to be reported as AE’s is always the question.

Objectives of the Presentation:
  • The purpose of the Safety Monitoring Plan in a Protocol
  • The Regulatory requirements of Adverse Event reporting
  • Studies requiring a specific type of Lab test
  • What do the "reference ranges" tell us?
  • When would an "out-of-range" lab value be an Adverse Event?
  • What types of studies depend on Laboratory and other testing?
  • Importance of good medical judgment in the process
Who can Benefit:
Those benefiting the most would be the Principal Investigators and sub investigators, Clinical Research Scientists (PKs, Biostatisticians, ...), Safety Nurses, Clinical Research Associates (CRAs) and Coordinators (CRCs), Recruiting staff, QA / QC auditors and staff, & Clinical Research Data managers In addition, the holders of the IND for new products i.e. the Sponsors will benefit.

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Instructor Profile:
Charles H Pierce is President of the virtual CRO Global Clinical Partners, Inc and Pierce One Consulting. From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal Investigator), Charles has an experienced based knowledge of the Clinical Research part of Drug Development.

He is an APPI/APCR Certified Principal Investigator (CPI in 2003 and recertification’s to 2016). He is actively involved in Webinars, courses and workshops.

Charles’ active management experience in the medical research industry gives him first-hand practical experience and knowledge to develop Phase I, IIa confined study Clinical Pharmacology Units (CPU’s). Charles is a Fellow and Life Member of the American Academy of Family Physicians and Emeritus fellow of the American College of Clinical Pharmacology (ACCP) and the 2004 recipient of the Nathaniel Kwitt Distinguished Service Award. He is an active member of the Association of Clinical Pharmacology Units (ACPU). He is also a member of the Academy of Physicians in Clinical Research (APCR) and the 2012 Chair of the Board to trustees of the Academy of the Association of Clinical Research Professionals (ACRP).
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